Manufacturing Engineer II
Core
Develops robust, cost-effective, and safe manufacturing processes and equipment for medical technology products, supporting the transfer of new products into commercial production.
Role type
Manufacturing Engineer II (Process & Equipment)
Builds
Manufacturing processes, equipment, tooling, and validation documentation for medical devices
Domain
Medical Technology / Manufacturing Engineering
Required skills
Process optimization, Equipment selection and design, DFSS/DMAIC methodologies, Process validation (IQ/OQ/PQ), PFMEA, Lean methodologies, Calibration management, Technical reporting, Regulatory compliance
Preferred skills
Mechanical, Chemical, or Biomedical engineering background
Technologies
DFSS, DMAIC, PFMEA, Calibration Management Systems, Lean tools
Responsibilities
Support design, optimization, validation, and troubleshooting of process technologies; Provide input to equipment vendors for new tooling and material selection; Execute experimentation and testing to characterize process performance; Support installation, calibration, and EHS assessment of new equipment; Apply Lean methodologies to eliminate process waste; Ensure compliance with quality system regulations and standards; Develop and release validation documentation (FMEA, Validation Plans, protocols); Perform equipment calibration services and maintain measurement traceability; Train technicians on calibration procedures; Support budget development and audit activities.
Seniority
Mid-level (3-5 years experience), works under supervisory direction with mentor assistance